Section 64815 - Quality Assurance(a) Each laboratory shall develop and implement a quality assurance program to assure the reliability and validity of the analytical data produced by the laboratory. As evidence of such a program, the laboratory shall develop and maintain a quality assurance program manual.(b) The quality assurance program manual shall address all quality assurance and quality control practices to be employed by the laboratory and shall, at least, include the quality assurance and quality control requirements specified in the test methods for which the laboratory holds, or seeks, certification. The manual shall include the following elements: laboratory organization and personnel responsibilities; quality assurance objectives for measurement data; sampling procedures (when the laboratory performs the sampling); custody, handling, and disposal of samples; calibration procedures and frequency; analytical procedures; acquisition and reduction, validation and reporting of data; internal quality control checks; performance and system audits; preventive maintenance; assessment of precision and accuracy; corrective action; and quality assurance reports.(c) The Laboratory Director shall review, and amend if necessary, the quality assurance program and quality assurance program manual at least annually. The Laboratory Director shall also review and amend the quality assurance program and manual whenever there are changes in methods or laboratory equipment employed, in the laboratory structure or physical arrangements, or changes in the laboratory organization.(d) A laboratory shall maintain records of the implementation of its quality assurance program, and provide those records upon request of the Department. Records shall be maintained for a minimum of three years.Cal. Code Regs. Tit. 22, § 64815
Note: Authority cited: Sections 208 and 1011, Health and Safety Code. Reference: Section 1012, Health and Safety Code.
1. New article 8 and section filed 12-2-94; operative 12-2-94 pursuant to Government Code section 11346.2(d) (Register 94, No. 48).